By 2027, the global market for aseptic processing is expected to reach USD 12.5 billion by 2027. This demand has been largely driven by the increased demand for parenteral drugs, which require strict sterility procedures to ensure they are safe for use.
Because parenteral drugs are injected directly into the bloodstream, they bypass many of the body’s natural defences. This means that any contaminants present in the formulation can cause serious issues in aseptic processing during the manufacturing process.
So how can pharmaceutical manufacturers work with parenteral products to ensure careful handling? Let’s discuss.
Aseptic sterility challenges
Drug products requiring aseptic processing are not subject to a terminal sterilisation step; instead, sterility is assured through the prevention of any microbial ingress to the product during manufacturing until the final filling is complete.
If aseptic processing is carried out improperly and microbial contamination takes place, drug companies run the risk of:
● Loss of drug product
● Significant production delays
● Potential for serious health consequences for patients
Maintaining such high levels of sterility across production lines requires companies to implement highly specialised equipment, infrastructure and operating processes.
For effective aseptic processing to take place, companies must ensure close coordination between:
● Personnel
● Product
● Equipment systems
● Regular cleaning regimes
● Air classification measures
● Cleanroom facilities
● Support components
● Drug product transfer processes
Regulatory handling requirements for aseptic processing
The latest revision to Annex 1 of the Good Manufacturing Practices (GMP) has been published, with significant regulatory guidelines that drug manufacturers must follow for their aseptic processes.
A crucial element of the latest revisions to Annex 1 is that it considers the latest technological advancements now becoming more widespread in cleanrooms. In recent years there has been an influx of advancements in aseptic processing technologies, helping to further minimise potential contamination in the cleanroom spaces.
For example, advancements in drug transfer technologies now enable manufacturers to declassify the surrounding environment whilst providing an aseptic transfer – provided that all other aspects of Annex 1 are followed.
One example of these advanced technologies is the aseptic Split Butterfly Valve (SBV). Widely used across cleanroom production lines, the SBV is a stainless steel device consisting of two components. One ‘active’ part and one ‘passive’, they form a single ‘butterfly’ disk, which connects to filling lines and allows the drug product to flow from the line into the container, preventing any contact with the outside environment.
Single use technologies
Another example of recent technological advances used across production lines is single use technologies (SUTs). Across the biologic market, SUTs are in high demand, with the market expected to reach US $43.33 billion by the end of 2031.
SBV SUTs offer the same level of sterility across aseptic processes as their stainless steel counterparts, but remove the requirement for cleaning and validation processes. This makes them ideal for meeting compliance needs while optimising manufacturing capacity for parenteral drug production.
Another SUT used increasingly across cleanrooms is the single use Chargebag which offers further efficiencies across production lines.
By creating a sealed environment, they reduce the risk of ingress or egress of materials from or into the surrounding environment, and are designed to be disposed of after use to reduce the need for lengthy cleaning and validation procedures while ensuring compliance.
Looking ahead
As regulations and technologies continue to evolve at such a rapid pace, companies must be sure to partner with the right aseptic processing experts to not only meet regulatory obligations, but also streamline their existing sterility processes.
By doing so, they’re backed by the assurance that they are supported in ensuring that their existing and any new aseptic processing lines are fit for purpose and futureproof for many years to come.
Explore our range of sterility assurance solutions and find the right equipment to enhance your aseptic processing procedures.
